Early Phase Clinical Immunogenicity of Valoctocogene Roxaparvovec, an AAV5-Mediated Gene Therapy for Hemophilia A

Autor: Nina Mitchell, Wing Yen Wong, Federico Mingozzi, M. Benjamin Hock, Kelly Lau, Romain Hardet, Mingjin Li, Brian Long, Klaudia Kuranda, Stephen J. Zoog, Gregory M. Hayes, Becky Schweighardt, Christian Vettermann, Philippe Veron

Publikováno v: Molecular Therapy
Molecular Therapy, Cell Press, 2021, 29 (2), pp.597-610. ⟨10.1016/j.ymthe.2020.12.008⟩
Molecular Therapy, 2021, 29 (2), pp.597-610. ⟨10.1016/j.ymthe.2020.12.008⟩

Evaluation of immune responses to adeno-associated virus (AAV)-mediated gene therapies prior to and following dose administration plays a key role in determining therapeutic safety and efficacy. This report describes up to 3 years of immunogenicity d

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ee02e7080dc601adb5748d6fb5af6de1
https://doi.org/10.1016/j.ymthe.2020.12.008

Clinical immunogenicity of the d -amino acid peptide therapeutic etelcalcetide: Method development challenges and anti-drug antibody clinical impact assessments

Autor: Raju Subramanian, Hongjie Deng, Michael Serenko, M. Benjamin Hock, Dohan Weeraratne, Benjamin M. Wu, Bethlyn Sloey, Mark A. Kroenke

Publikováno v: Journal of Immunological Methods. 445:37-44

The immunogenicity risk assessment and bioanalytical strategy for novel therapeutics should account for both unique biophysical properties and potential consequences of immunogenicity. When assessing the immunogenicity risk of etelcalcetide, a peptid

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::718313f79cd3460738bf11f15ada8c3a
https://doi.org/10.1016/j.jim.2017.03.005

LATE BREAKING NEWS E-POSTER PRESENTATION

Autor: Charles O'Neill, Mika Aoyagi-Scharber, Jukka Poulivali, Sundeep Chandra, Ashley Frazer-Abel, Maria Hedlund, Nicole A. Datson, Andrew Melton, David Jacoby, M Benjamin Hock, Ganesh Cherala, Sylvia Fong, Todd M. Oppeneer, Judith C.T. van Deutekom, Shripad Bhagwat, Xiefan Fang

Publikováno v: Neuromuscular Disorders. 30:S169

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::62757f5a5f388bc014db46727eef5769
https://doi.org/10.1016/j.nmd.2020.09.015

Clinical Pharmacokinetics and Pharmacodynamics of Etelcalcetide, a Novel Calcimimetic for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis

Autor: Edward Lee, Murad Melhem, Ping Chen, Bethlyn Sloey, Raju Subramanian, Andrew T. Chow, M. Benjamin Hock, Gary L. Skiles, Benjamin Wu, Bruno Fouqueray

Publikováno v: Journal of clinical pharmacology. 58(6)

Etelcalcetide, a d-amino acid peptide, is an intravenous calcimimetic approved for the treatment of secondary hyperparathyroidism. Etelcalcetide binds the calcium-sensing receptor and increases its sensitivity to extracellular calcium, thereby decrea

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::86d7f592947b6b3e12329dec334b5e44
https://pubmed.ncbi.nlm.nih.gov/29534286

Placental Transfer of a Fully Human IgG2 Monoclonal Antibody in the Cynomolgus Monkey, Rat, and Rabbit: A Comparative Assessment from during Organogenesis to Late Gestation

Autor: Colin Hall, Elise M. Lewis, Graeme J. Moffat, M. Benjamin Hock, Marc W. Retter, Mark Loomis, Jeanine L. Bussiere, Gary J. Chellman, Gayle Kwon

Publikováno v: Birth Defects Research Part B: Developmental and Reproductive Toxicology. 101:178-188

Understanding species differences in the placental transfer of monoclonal antibodies is important to inform species selection for nonclinical safety assessment, interpret embryo-fetal changes observed in these studies, and extrapolate their human rel

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::0b4f02f1f492c329518197add37bfc60
https://doi.org/10.1002/bdrb.21105